Occlusion detection devices, systems, and methods

ABSTRACT

A monitoring device may include a housing, which may include a distal end, a proximal end, and a fluid pathway extending through the proximal end and distal end. The distal end may include a connector configured to couple to a catheter assembly. The monitoring device may include one or more sensors disposed within the fluid pathway. The sensors may facilitate identification of an occlusion within the catheter assembly.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/841,398, filed Apr. 6, 2020, and entitled OCCLUSION DETECTIONDEVICES, SYSTEMS, AND METHODS, which claims the benefit of U.S. PatentApplication No. 62/830,707, filed Apr. 8, 2019, and entitled OCCLUSIONDETECTION DEVICES, SYSTEMS, AND METHODS, which are incorporated hereinin their entirety.

BACKGROUND

Infusion therapy, a common healthcare procedure, may be facilitated by avascular access device. Hospitalized, home care, and other patientsoften receive fluids, pharmaceuticals, and blood products via thevascular access device. Blood withdrawal is another common healthcareprocedure that may be facilitated by the vascular access device.

The vascular access device may insert a peripheral and/or centralvasculature of a patient. The vascular access device may be indwellingfor short term (days), moderate term (weeks), or long term (months toyears). The vascular access device may be used for continuous infusiontherapy or for intermittent infusion therapy. A common type of vascularaccess device is a catheter, such as, for example, a peripheralintravenous catheter (PIVC) or a peripherally inserted central catheter(PICC).

When the catheter remains in the vasculature of the patient for aprolonged period of time, the catheter may become more susceptible to anocclusion or blockage by debris (e.g., fibrin or platelet clots). Theocclusion can lead to catheter infection, pulmonary embolism,post-thrombotic syndrome, and other negative health outcomes. Also, whenthe occlusion in the catheter occurs, the catheter may be removed and/orreplaced, which may result in an additional needle stick, pain to thepatient, and higher material costs.

Currently clinicians are left to their own judgment to assess whether ornot the catheter is occluded. The clinician may judge whether thecatheter is partially or fully occluded based on difficulty in gettingblood return or by syringe pressure. Clinicians may not be well equippedto judge whether the catheter is nearing full occlusion. In response tomaking a judgment that the catheter is partially or fully occluded, theclinician may intervene to clear the occlusion.

Current occlusion removal or prevention measures include manuallyflushing the catheter. Also, a thrombolytic agent may be used to breakup the occlusion in the catheter. However, the thrombolytic agent isoften expensive and installation of the thrombolytic agent may interruptinfusion therapy through the catheter.

The subject matter claimed herein is not limited to embodiments thatsolve any disadvantages or that operate only in environments such asthose described above. Rather, this background is only provided toillustrate a technology area where some implementations described hereinmay be practiced.

SUMMARY

The present disclosure relates generally to a monitoring device tomonitor a status of a catheter, which may be indwelling in a vasculatureof a patient. In some embodiments, the catheter may include a PIVC, aPICC, or a midline catheter. In some embodiments, the monitoring devicemay include a housing that includes a distal end, a proximal end, and afluid pathway extending through the proximal end of the housing and thedistal end of the housing.

In some embodiments, the distal end of the housing may include aconnector configured to couple to a catheter assembly, which may includethe catheter. In some embodiments, the distal end of the housing mayinclude another connector. In some embodiments, the distal end of thehousing and/or the proximal end of the housing may include a luerconnector.

In some embodiments, the monitoring device may include one or moresensors disposed within the fluid pathway. In some embodiments, themonitoring device may include a communication unit configured towirelessly transmit an output signal to a receipt location. In someembodiments, the output signal may be based on data sensed by thesensors. In some embodiments, the housing may include one or more of thefollowing: a printed circuit board, a power supply, and an electricalcontact. In some embodiments, the communication unit and/or a processormay be disposed on the printed circuit board.

In some embodiments, the monitoring device may include another housingthat may be removably coupled to the housing. In some embodiments, theother housing may include one or more of the following: the printedcircuit board, the power supply, and another electrical contact. In someembodiments, the other electrical contact of the other housing may beoperably connected to the electrical contact of the housing, which mayfacilitate communication between the sensors disposed within the housingand the printed circuit board within the other housing.

In some embodiments, at least one of the sensors disposed within thefluid pathway may include a pressure sensor, which may be configured todetect a fluid pressure of fluid within the fluid pathway. In someembodiments, at least one of the sensors may include a flow sensor,which may be configured to detect a fluid flow rate and/or a fluid flowvolume within the fluid pathway. In some embodiments, the monitoringdevice may include another pressure sensor that may be placed proximalto the pressure sensor.

In some embodiments, the printed circuit board may include theprocessor. In some embodiments, presence of an occlusion in the catheterassembly may be determined based on the data sensed by the sensors. Insome embodiments, the occlusion may be partial, partially blocking fluidflow through the catheter assembly, or full, fully or substantiallyfully blocking fluid flow through the catheter assembly. In someembodiments, in response to determining the presence of the occlusionbased on the data sensed by the sensor and/or the other sensor, thecommunication module may wirelessly transmit the output signal to thereceipt location.

In some embodiments, in response to receipt of the output signal by thereceipt location, an alert may be provided at the receipt location. Insome embodiments, the alert may include a sound, a tactile vibration, ora visual cue, such as, for example, a change in status of a light. Insome embodiments, an indicator at the receipt location may be configuredto provide the alert. Additionally or alternatively, in someembodiments, an indicator on the housing and/or the other housing may beconfigured to provide the alert in response to the determining thepresence of the occlusion.

In some embodiments, the monitoring device may transmit the outputsignal to the receipt location via a network. In some embodiments, thereceipt location may include a patient electronic medical record, astorage device, a smartphone or another mobile device, a computerserver, a barcode scanner, a laptop computer, a nurse station, aprinter, or another suitable receipt location.

In some embodiments, a method of determining the presence of theocclusion in the catheter assembly may include coupling the monitoringdevice to the catheter assembly, which may be indwelling. In someembodiments, the method may include determining the presence of theocclusion within the catheter assembly based on the data sensed by thesensors. In some embodiments, the method may include transmitting theoutput signal from the communications module to the receipt location inresponse to determining the presence of the occlusion within thecatheter assembly.

In some embodiments, determining the presence of the occlusion withinthe catheter assembly based on the data sensed by the sensors mayinclude determining the occlusion is partial in response to the sensorsdetecting a mean maximum pressure between 14 psi and 42.5 psi within thefluid pathway. In some embodiments, the method may include providing thealert in response to determining the occlusion is partial. In someembodiments, determining the presence of the occlusion within thecatheter assembly based on the data sensed by the sensors may includedetermining the occlusion is full in response to the sensors detecting amean maximum pressure of at least 42.5 psi. In some embodiments, themethod may include providing the alert in response to determining theocclusion is full.

In some embodiments, determining the presence of the occlusion withinthe catheter assembly based on the data sensed by the sensors mayinclude determining a pressure, such as the mean maximum pressure,within the catheter assembly is greater than a threshold value. In someembodiments, the sensors may include a first pressure sensor and asecond pressure sensor, which may be disposed proximal to the firstpressure sensor within the fluid pathway. In some embodiments, themethod may include determining a fluid flow direction within thecatheter assembly based on the data sensed by the first pressure sensorand the second pressure sensor.

In some embodiments, the sensors may include a first flow sensor and asecond flow sensor, which may be disposed proximal to the first flowsensor within the fluid pathway. In some embodiments, the method mayinclude determining a fluid flow direction within the catheter assemblybased on the data sensed by the first flow sensor and the second flowsensor.

It is to be understood that both the foregoing general description andthe following detailed description are examples and explanatory and arenot restrictive. It should be understood that the various embodimentsare not limited to the arrangements and instrumentality shown in thedrawings. It should also be understood that the embodiments may becombined, or that other embodiments may be utilized and that structuralchanges, unless so claimed, may be made without departing from the scopeof the various embodiments of the present disclosure. The followingdetailed description is, therefore, not to be taken in a limiting sense.

BRIEF DESCRIPTION OF SEVERAL VIEWS OF THE DRAWINGS

Example embodiments of the invention will be described and explainedwith additional specificity and detail through the use of theaccompanying drawings in which:

FIG. 1A is an upper perspective view of an example monitoring devicecoupled to an example catheter assembly, according to some embodiments;

FIG. 1B is an upper perspective view of the monitoring device of FIG.1A, according to some embodiments;

FIG. 2A is a partial cutaway view of the monitoring device of FIG. 1A,according to some embodiments;

FIG. 2B is another partial cutaway view of the monitoring device of FIG.1A, illustrating an example circuit board, example battery, and examplesensors removed, according to some embodiments;

FIG. 2C is a cross-sectional view of the monitoring device of FIG. 1Aalong the line 2C-2C of FIG. 2A, according to some embodiments;

FIG. 2D is another partial cutaway view of the monitoring device of FIG.1A, according to some embodiments;

FIG. 2E is another partial cutaway view of the monitoring device of FIG.1A, according to some embodiments;

FIG. 3A is an exploded view of another example monitoring device,according to some embodiments;

FIG. 3B is an upper perspective view of the monitoring device of FIG.3A, according to some embodiments;

FIG. 3C is a bottom view of a first housing of the monitoring device ofFIG. 3A, according to some embodiments;

FIG. 3D is a side view of the monitoring device of FIG. 3A, according tosome embodiments;

FIG. 4 is an upper perspective view of an example receipt location,according to some embodiments; and

FIG. 5 is a block diagram of an example monitoring system, according tosome embodiments.

DESCRIPTION OF EMBODIMENTS

Referring now to FIG. 1A, an example catheter system 10 is illustrated,according to some embodiments. In some embodiments, the catheter system10 may include a monitoring device 12 and a catheter assembly 16, whichmay be coupled to the monitoring device 12.

In some embodiments, the catheter assembly 16 may include a catheteradapter 18 and a catheter 20 extending distally from the catheteradapter 18. In some embodiments, the catheter adapter 18 may include aside port 22 in fluid communication with the lumen of the catheteradapter 18. In some embodiments, the catheter adapter 18 may include aproximal end 23, a distal end 24, and a lumen extending there between.In some embodiments, the catheter 20 may include a PIVC, a PICC, or amidline catheter.

In some embodiments, the catheter assembly 16 may be removably coupledto a needle assembly, which may include a needle hub 26 and anintroducer needle 28. In some embodiments, the introducer needle 28 mayinclude a sharp distal tip 30. In some embodiments, a proximal end ofthe introducer needle 28 may be secured within the needle hub 26. Insome embodiments, the introducer needle 28 may extend through thecatheter 20 when the catheter assembly 16 is in an insertion positionready for insertion into vasculature of a patient, as illustrated, forexample, in FIG. 1A. In some embodiments, in response to the introducerneedle 28 being inserted into the vasculature of the patient, bloodflashback may flow through the sharp distal tip 30 of the introducerneedle 28 and may be visible to a clinician between the introducerneedle 28 and the catheter 20 and/or at another location within thecatheter assembly 16.

In some embodiments, in response to confirmation via the blood flashbackthat the catheter 20 is positioned within vasculature of the patient,the needle assembly may be removed from the catheter assembly 16. Insome embodiments, when the needle assembly is coupled to the catheterassembly 16, as illustrated, for example, in FIG. 1A, the introducerneedle 28 of the needle assembly may extend through a septum disposedwithin the lumen of the catheter adapter 18.

In some embodiments, the catheter assembly 16 may include an extensiontube 34. In some embodiments, a distal end of the extension tube 34 maybe integrated with the catheter adapter 18, as illustrated, for example,in FIG. 1A. For example, the extension tube 34 may be integrated withthe side port 22 of the catheter adapter 18. In some embodiments, theextension tube 34 may be removably coupled to the catheter adapter 18.

In some embodiments, an adapter 38 may be coupled to a proximal end ofthe extension tube 34. In some embodiments, the adapter 38 may include aY-adapter or another suitable connector. In some embodiments, aneedleless connector 40 may be coupled to the adapter 38. In someembodiments, the adapter 38 and/or the needleless connector 40 may beused to couple the catheter 20 with the monitoring device 12. In someembodiments, a medical device for fluid administration or bloodwithdrawal may be coupled to a proximal end of the monitoring device 12.The medical device may include a transfusion bag, syringe, or any othersuitable medical device.

Referring now to FIG. 1B, in some embodiments, the monitoring device 12may include a housing 42, which may include a distal end 44, a proximalend 46, and a fluid pathway 48 extending through the proximal end 46 andthe distal end 44. In some embodiments, the distal end 44 may include aconnector configured to couple to the catheter assembly 16. In someembodiments, the proximal end 46 may include another connector. In someembodiments, the connector and/or the other connector may include a maleor female Luer connector. In some embodiments, the Luer connector mayinclude a Luer-slip or a Luer-lock feature.

Referring now to FIG. 2A-2E, in some embodiments, the monitoring device12 may include one or more sensors within the fluid pathway 48. In someembodiments, the fluid pathway 48 may be in fluid communication with afluid pathway extending through the catheter assembly 16. Thus, bydetecting conditions within the fluid pathway 48, the sensors may detectconditions within the fluid pathway extending through the catheterassembly 16.

As illustrated, for example, in FIG. 2A-2C, in some embodiments, thesensors may include a flow sensor 50 and/or a pressure sensor 52. Insome embodiments, the flow sensor 50 may be disposed distal to thepressure sensor 52. In some embodiments, the flow sensor 50 may bedisposed proximal to the pressure sensor 52. For example, a position ofthe flow sensor 50 and the pressure sensor 52 may be reversed from thatillustrated in FIG. 2A. In some embodiments, the sensors may bepositioned at various locations with respect to the fluid pathway 48.

In some embodiments, the flow sensor 50 may be configured to detect afluid flow rate and/or a fluid flow volume within the fluid pathway 48.In some embodiments, the pressure sensor 52 may be configured to detecta fluid pressure of fluid within the fluid pathway 48. In someembodiments, the fluid pathway 48 may be enclosed within the housing 42such that fluid may not leak out of the fluid pathway 48 as the fluidflows between the distal end 44 and the proximal end 46. In someembodiments, the fluid pathway 48 may extend through a tunnel 54, whichmay include one or more holes 56 through which the sensors may extend toenclose the fluid pathway 48.

In some embodiments, the flow sensor 50 may include any suitable flowsensor that may detect fluid flow through the fluid pathway 48. Varioussuitable fluid flow sensors are well known, and may be used.Illustrative examples of suitable fluid flow sensors may include, butare not limited to, optical sensors, piezoelectric sensors, soundsensors, reed switch-based sensors, magnetic sensors, ultrasoundsensors, orifice type flow meters, venturi flow meters, and the like.

In some embodiments, the flow sensor 50 may include a thermal flowmeter. In some embodiments, the thermal flow meter may include a heater,which may heat the fluid travelling through the fluid pathway 48. Insome embodiments, the thermal flow meter may be configured to measurethe fluid temperature at an upstream point and a downstream point withinthe fluid pathway 48. In some embodiments, fluid flow rate may bedetermined based on a temperature difference between the upstream pointand the downstream point. In some embodiments, the heater may becontrolled to constantly maintain a fixed temperature, and the fluidflow rate may be determined based on an amount of power necessary tomaintain the fixed temperature. An example flow sensor may be describedin U.S. Pat. No. 5,533,412, filed Jun. 7, 1995, entitled “PULSED THERMALFLOW SENSOR SYSTEM,” which is hereby incorporated by reference in itsentirety.

In some embodiments, the pressure sensor 52 may include any suitableflow sensor that may detect fluid pressure within the fluid pathway 48.In some embodiments, the pressure sensor 52 may include a pressuresensitive device, which may be capacitive, resistive, optical, orultrasonic. In some embodiments, a first surface of the pressure sensor52 may be exposed to the fluid within the fluid pathway 48 and a secondsurface of the pressure sensor 52 (i.e., the reference surface) may beexposed to a liquid or gas at a reference pressure. In some embodiments,the measured pressure differential between the first surface and thesecond surface of the pressure sensor 52 may provide an indication ofthe fluid pressure to which the first surface is exposed.

In some embodiments, the monitoring device 12 may include acommunication unit 58 configured to wirelessly transmit an output signalto a receipt location. In some embodiments, the output signal may bebased on data sensed by the sensors. In some embodiments, a printedcircuit board (“PCB”) 60 and/or a power supply 62 may be disposed withinthe housing 42. In some embodiments, the power supply 62 may include abattery, which may be rechargeable and/or replaceable. In someembodiments, a location of the PCB 60 and/or the power supply 62 withinthe housing 42 may vary.

In some embodiments, the power supply 62 may be electrically coupled tothe sensors and may be configured to power the sensors. In someembodiments, the power supply 62 may be remotely disposed from the PCB60 and even the catheter assembly 16. In some embodiments, anon-volatile memory storage location, such as flash memory for instance,may be included on the PCB 60 to enable data sensed by the sensors to betemporarily or permanently stored thereon. In some embodiments, thestorage location may be accessible by a user and/or can be transmittedto the receipt location.

In some embodiments, the communication unit 58 and/or a processor may bedisposed on the PCB 60, which may be electrically coupled to thesensors. In some embodiments, presence of an occlusion in the catheterassembly 16 may be determined based on the data sensed by the sensors.In some embodiments, the occlusion may be partial, partially blockingfluid flow through the catheter assembly, or full, fully orsubstantially fully blocking fluid flow through the catheter assembly.In some embodiments, in response to the determining the presence of theocclusion based on the data sensed by the sensors, the communicationunit 58 may wirelessly transmit the output signal to the receiptlocation.

In some embodiments, in response to receipt of the output signal by thereceipt location, an alert may be provided at the receipt location. Insome embodiments, the alert may include a sound, a tactile vibration, ora visual cue, such as, for example, a change in status of a light. Insome embodiments, an indicator at the receipt location may be configuredto provide the alert.

Additionally or alternatively, in some embodiments, an indicator on thehousing 42 may be configured to provide the alert in response to thedetermining the presence of the occlusion. In some embodiments, theindicator may include one or more of lights, which may be arranged invarious configurations. Referring back to FIG. 1B, in some embodiments,the alert may include a visual cue, which may include a change in statusof one or more lights 64. For example, one or more of the lights 64 mayturn on or change color in response to the determining the presence ofthe occlusion, such as a partial occlusion or a full occlusion.

Referring back to FIGS. 2A-2E, in some embodiments, presence of a gasbubble in the fluid pathway 48 may be determined in response to thepressure sensor 52 detecting a drop in fluid pressure within the fluidpathway 48. In some embodiments, a magnitude of the drop may be greaterthan a predetermined threshold value. In some embodiments, the indicatoron the housing 42 and/or at the receipt location may be configured toprovide the alert in response to the determining the presence of the gasbubble.

In some embodiments, the monitoring device 12 may transmit the outputsignal to the receipt location via a network. In some embodiments, thereceipt location may include a patient electronic medical record, astorage device, a smartphone or another mobile device, a computerserver, a barcode scanner, a laptop computer, a nurse station, aprinter, or another suitable receipt location.

In some embodiments, as illustrated, for example, in FIG. 2D, thesensors may include at least two pressure sensors, which may include orcorrespond to the pressure sensor 52 of FIG. 2A. In some embodiments,the two pressure sensors may provide a more robust determination of anocclusion within the catheter system 10 and/or may facilitatedetermination of fluid flow direction within the fluid pathway 48. Insome embodiments, the fluid flow direction may be determined in responseto a first of the two pressure sensors detecting an increase in fluidpressure within the fluid pathway 48 prior to or after a second of thetwo pressure sensor.

In some embodiments, the gas bubble in the fluid pathway 48 may bedetermined in response to one or more of the two pressure sensorsdetecting a drop in fluid pressure within the fluid pathway 48. In someembodiments, a direction of travel of the gas bubble may be determinedin response to the first of the two pressure sensors detecting adecrease in fluid pressure within the fluid pathway 48 prior to or afterthe second of the two pressure sensors.

In some embodiments, as illustrated, for example, in FIG. 2E, thesensors may include at least two flow sensors, which may include orcorrespond to the flow sensor 50 of FIG. 2A. In some embodiments, thefluid flow direction may be determined in response to a first of the twoflow sensors detecting an increase in fluid pressure within the fluidpathway 48 prior to or after a second of the two flow sensors.

Referring now to FIG. 3A-3D, in some embodiments, another housing 66 maybe removably coupled to the housing 42. In some embodiments, the otherhousing 66 may include one or more of the following: the PCB 60, thepower supply 62, and one or more electrical contacts 68. In someembodiments, the housing 42 may include one or more other electricalcontacts 70, which may be operably coupled to the electrical contacts 68of the other housing 66 such that the power supply 62 may provide powerto the sensors and/or data from the sensors may be transmitted to thePCB 60.

In some embodiments, the housing 42 and the other housing 66 may becoupled together via any suitable coupling mechanism, including, forexample, threading, a snap fit, an interference fit, friction, or anadhesive. In some embodiments, the housing 42 or the other housing 66may include a groove or cavity 71. In some embodiments, the housing 42or the other housing 66 may include a protrusion 72, which may beconfigured to fit snugly within the cavity 71.

In some embodiments, the housing 42 may be disposable after use, and theother housing 66 may be reusable. In some embodiments, the other housing66 may be cleaned and reused for care of other patients. In someembodiments, the other housing 66 may be uncoupled from the housing 42and coupled to another housing similar to the housing 42. In someembodiments, placement of the PCB 60 and/or the communication unit 58 inthe other housing 66 may provide space in the housing 42 for the sensorsand/or may prevent replacement of the PCB 60, a relatively expensivecomponent, when the housing 42 is replaced.

In some embodiments, the other housing 66 may include the indicatorconfigured to provide the alert in response to determining the presenceof the occlusion. For example, the other housing 66 may include thelights 64, which may be arranged in various configurations. In someembodiments, the lights 64 and/or descriptions proximate the lights 64may be arranged as illustrated, for example, in FIG. 1B. In someembodiments, the lights 64 may turn on or change color in response todetermining the presence of the occlusion, such as a partial occlusionor a full occlusion indicator. In some embodiments, the housing 42and/or the other housing 66 may include a display 74, which may be theindicator.

Referring now to FIG. 4 , an example receipt location is illustrated,according to some embodiments. In some embodiments, the receipt locationmay include a clinician monitoring device 76. Examples of the clinicianmonitoring device 76 may include a computing device, a mobile phone, asmartphone, a tablet computer, a laptop computer, a desktop computer, amedical device, or a connected device (e.g., a smartwatch, smartglasses, or any other connected device). In some embodiments, inaddition to or as an alternative to the monitoring device 12 providingthe alert, the clinician monitoring device 76 may provide the alert. Insome embodiments, the clinician monitoring device 76 may include a pump,which may be coupled to the proximal end 46 of the monitoring device 12and configured to infuse the catheter system 10 in response to receiptof the output signal.

In some embodiments, the clinician monitoring device 76 may include adisplay screen 78, which may provide the alert. In some embodiments, thealert may include a phrase such as, for example, “Partial Occlusion” or“Full Occlusion.” In some embodiments, the alert may include a visualcue on the display screen 78, such as a portion 80 of the display screen78 that lights up or changes color. In some embodiments, the portion 80of the display screen 78 may blink or change a rate of blinking toprovide the alert. In some embodiments, an electronic health record thatmay be presented on the display screen 78 of the clinician monitoringdevice 76.

FIG. 5 is as block diagram of the monitoring device 12, arranged inaccordance with at least one embodiment described in the presentdisclosure. In some embodiments, the monitoring device 12 may include acomputing system 82, which may include the PCB 60, described, forexample, with respect to FIG. 2A.

In some embodiments, the computing system 82 may include a processor 84,a memory 86, a data storage 88, and a communication unit 58. In someembodiments, the processor 84, the memory 86, the data storage 88, andthe communication unit 58 may be communicatively coupled by a bus 90.The bus 90 may include, but is not limited to, a controller area network(CAN) bus, a memory bus, a storage interface bus, a bus/interfacecontroller, an interface bus, or the like or any combination thereof. Insome embodiments, the processor 84 may include a timer 98. In someembodiments, the timer 98 may be a separate component linked to theprocessor 84.

In general, the processor 84 may include any suitable special-purpose orgeneral-purpose computer, computing entity, or processing deviceincluding various computer hardware or software modules and may beconfigured to execute instructions stored on any applicablecomputer-readable storage media. For example, the processor 84 mayinclude a microprocessor, a microcontroller, a digital signal processor(DSP), an application-specific integrated circuit (ASIC), aField-Programmable Gate Array (FPGA), or any other digital or analogcircuitry configured to interpret and/or to execute program instructionsand/or to process data. Although illustrated as a single processor inFIG. 5 , the processor 84 may include any number of processorsconfigured to perform, individually or collectively, any number ofoperations described in the present disclosure. Additionally, one ormore of the processors 84 may be present on one or more differentelectronic devices.

In some embodiments, the processor 84 may interpret and/or executeprogram instructions and/or process data stored in the memory 86, thedata storage 88, or the memory 86 and the data storage 88. In someembodiments, the processor 84 may fetch program instructions from thedata storage 88 and load the program instructions in the memory 86. Insome embodiments, after the program instructions are loaded into memory86, the processor 84 may execute the program instructions.

For example, in some embodiments, an occlusion module 92 may be includedin the data storage 88 as program instructions. In some embodiments, theocclusion module 92 may be configured to manage flow conditions in acatheter system, such as, for example, the catheter system 10, describedwith respect to FIG. 1 . The processor 84 may fetch the programinstructions of the occlusion module 92 from the data storage 88 and mayload the program instructions of the occlusion module 92 in the memory86. After the program instructions of the occlusion module 92 are loadedinto the memory 86, the processor 84 may execute the programinstructions such that the computing system 82 may implement theoperations associated with the occlusion module 92 as directed by theinstructions.

The memory 86 and the data storage 88 may include computer-readablestorage media for carrying or having computer-executable instructions ordata structures stored thereon. Such computer-readable storage media mayinclude any available media that may be accessed by a general-purpose orspecial-purpose computer, such as the processor 84. By way of example,and not limitation, such computer-readable storage media may includetangible or non-transitory computer-readable storage media includingRAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic diskstorage or other magnetic storage devices, flash memory devices (e.g.,solid state memory devices), or any other storage medium which may beused to carry or store desired program code in the form ofcomputer-executable instructions or data structures and which may beaccessed by a general-purpose or special-purpose computer. Combinationsof the above may also be included within the scope of computer-readablestorage media. Computer-executable instructions may include, forexample, instructions and data configured to cause the processor 84 toperform a certain operation or group of operations.

In some embodiments, one or more clinician monitoring devices 87 may beconnected to the computing system 82 via a network 94. In these andother embodiments, the network 94 may include a wired or wirelessnetwork, and may have any suitable configuration, such as a starconfiguration, a token ring configuration, or other configurations.Furthermore, in some embodiments, the network 94 may include an Ethernetnetwork, a local area network (LAN), a wide area network (WAN) (e.g.,the Internet), and/or other interconnected data paths across whichmultiple devices may communicate. In some embodiments, the network 94may include a peer-to-peer network. In some embodiments, the network 94may also be coupled to or include portions of a telecommunicationsnetwork that may enable communication of data in a variety of differentcommunication protocols. In some embodiments, the clinician monitoringdevices 87 may include or correspond to the clinician monitoring device76 described with respect to FIG. 4 .

In some embodiments, the network 94 may include BLUETOOTH® communicationnetworks and/or cellular communications networks for sending andreceiving data including via short messaging service (SMS), multimediamessaging service (MMS), hypertext transfer protocol (HTTP), direct dataconnection, wireless application protocol (WAP), e-mail, etc. Thenetwork 94 may enable communication via a standard-based protocol suchas smart energy profile (SEP), Echonet Lite, OpenADR, or anothersuitable protocol (e.g., wireless fidelity (Wi-Fi), ZigBee, HomePlugGreen, etc.).

In some embodiments, the communication unit 58 may be configured totransmit data to and receive data from the clinician monitoring devices87 via the network 94. In some embodiments, the communication unit 58may also be configured to transmit and receive data from a displayscreen and/or an electronic health record 100. In some embodiments, thedisplay screen may include or correspond to the display screen 78described with respect to FIG. 4 . In some embodiments, the occlusionmodule 92 may be configured to send and receive data via thecommunication unit 58.

In some embodiments, the communication unit 58 may include a port fordirect physical connection to the network 94 and/or anothercommunication channel. For example, the communication unit 58 mayinclude a universal serial bus (USB) port, a secure digital (SD) port, acategory 5 cable (CAT-5) port, or similar port for wired communicationwith another device. In some embodiments, the communication unit 58 mayinclude a wireless transceiver for exchanging data with the clinicianmonitoring device 87 or other communication channels using one or morewireless communication methods, including IEEE 802.11, IEEE 802.16,BLUETOOTH®, or another suitable wireless communication method.

In some embodiments, the communication unit 58 may include a cellularcommunications transceiver for sending and receiving data over acellular communications network including via SMS, MMS, HTTP, directdata connection, WAP, e-mail, or another suitable type of electroniccommunication. The communication unit 58 may also provide otherconventional connections to the network 94 for distribution of files ormedia objects using standard network protocols including transmissioncontrol protocol/internet protocol (TCP/IP), HTTP, HTTP secure (HTTPS),and simple mail transfer protocol (SMTP).

In some embodiments, an example of how the occlusion module 92 maymanage flow conditions in a catheter assembly is now provided. In someembodiments, the occlusion module 92 may determine presence of anocclusion within the catheter assembly based on the data sensed bysensors, such as, for example, the sensors of the monitoring device 12described with respect to one or more of FIGS. 1A-3D. In someembodiments, the occlusion module 92 may be configured to transmit theoutput signal from the communications module to the receipt location inresponse to determining the presence of the occlusion within thecatheter assembly.

In some embodiments, the occlusion module 92 may be configured todetermine the occlusion is partial in response to the sensors detectinga mean maximum pressure between 14 psi and 42.5 psi within a fluidpathway proximate the sensors. In some embodiments, the occlusion module92 may be configured to generate an alert and/or output signal inresponse to determining the occlusion is partial. In some embodiments,the occlusion module 92 may be configured to determine the occlusion isfull in response to the sensors detecting a mean maximum pressure of atleast 42.5 psi. In some embodiments, the occlusion module 92 may beconfigured to generate the alert and/or the output signal in response todetermining the occlusion is full.

In some embodiments, the occlusion module 92 may be configured todetermine a pressure, such as the mean maximum pressure, within thecatheter assembly is greater than a threshold value. In someembodiments, the occlusion module 92 may be configured to determine afluid flow direction within the catheter assembly based on the datasensed by the sensors.

In some embodiments, an external server may include one or morecomponents of the computing system 82. In some embodiments, the externalserver may be connected to the monitoring device 12 and/or the clinicianmonitoring device 87 via the network 94 or another network.Modifications, additions, or omissions may be made to the computingsystem 82 without departing from the scope of the present disclosure.

All examples and conditional language recited herein are intended forpedagogical objects to aid the reader in understanding the invention andthe concepts contributed by the inventor to furthering the art, and areto be construed as being without limitation to such specifically recitedexamples and conditions. Although embodiments of the present inventionsmay be described in detail, it should be understood that the variouschanges, substitutions, and alterations could be made hereto withoutdeparting from the spirit and scope of the invention.

1-20. (canceled)
 21. A monitoring device for detecting when a catheteris partially occluded, comprising: a first housing comprising a topsurface, a distal end, a proximal end, a wall forming a tunnel extendingthrough the proximal end and the distal end, and a fluid pathwayextending through the tunnel, wherein the wall comprises a holeextending therethrough, wherein the distal end comprises a connectorconfigured to couple to a catheter assembly, the first housing furthercomprising: a sensor disposed and spaced apart within the fluid pathway,wherein the sensor is disposed within the hole, wherein the sensorencloses the fluid pathway within the tunnel between the distal end andthe proximal end of the first housing; a first electrical contact thatconnects to the sensor and is embedded in the top surface; and a groovein the top surface that extends from a first side of the first housingtowards a second side of the first housing opposite the first side ofthe first housing; and a second housing having a bottom surface, thesecond housing comprising: a computing system having a processor that isconfigured to receive data sensed by the sensor, the processor beingconfigured to detect, from the received data, when the catheter ispartially occluded but not yet fully occluded, the computing systemfurther comprising a communication unit by which the processorwirelessly transmits an output signal to a receipt location when theprocessor detects that the catheter is partially occluded; a secondelectrical contact that connects to the computing system, the secondelectrical contact being embedded in the bottom surface; and aprotrusion that extends downwardly from the bottom surface, theprotrusion extending from a first side of the second housing towards asecond side of the second housing opposite the first side of the secondhousing, the protrusion being configured to slide into the groove in thetop surface of the first housing to thereby secure the first housing tothe second housing, wherein the protrusion and the groove are configuredsuch that, when the protrusion is fully slid into the groove the bottomsurface is secured against and aligned with the top surface and thesecond electrical contact aligns with and contacts the first electricalcontact.
 22. The monitoring device of claim 21, wherein the processordetects that the catheter is partially occluded by detecting that thereceived data defines a mean maximum pressure between 14 psi and 42.5psi.
 23. The monitoring device of claim 21, wherein the second housingcomprises an indicator configured to provide an alert in response to theprocessor determining that the catheter is partially occluded.
 24. Themonitoring device of claim 23, wherein the second housing comprisesanother indicator configured to provide an alert in response to theprocessor determining that the catheter is fully occluded.
 25. Themonitoring device of claim 21, wherein the sensor comprises a pressuresensor configured to detect a fluid pressure of fluid within the fluidpathway.
 26. The monitoring device of claim 21, wherein the sensorcomprises a flow sensor configured to detect a fluid flow rate of thefluid within the fluid pathway.
 27. The monitoring device of claim 21,wherein the proximal end of the first housing comprises a luerconnector.
 28. The monitoring device of claim 21, wherein the processoris configured to wirelessly transmit another output signal to thereceipt location in response to detecting when the catheter is fullyoccluded.
 29. The monitoring device of claim 21, wherein the processordetects that the catheter is partially occluded by detecting that thereceived data defines a mean maximum pressure between two thresholdvalues.
 30. A method of determining flow conditions in a cathetersystem, comprising: coupling a monitoring device to a catheter assembly,wherein the monitoring device comprises: a first housing comprising atop surface, a distal end, a proximal end, a wall forming a tunnelextending through the proximal end and the distal end, and a fluidpathway extending through the tunnel, wherein the wall comprises a holeextending therethrough, wherein the distal end comprises a connectorconfigured to couple to a catheter assembly, the first housing furthercomprising: a sensor disposed and spaced apart within the fluid pathway,wherein the sensor is disposed within the hole, wherein the sensorencloses the fluid pathway within the tunnel between the distal end andthe proximal end of the first housing; a first electrical contact thatconnects to the sensor and is embedded in the top surface; and a groovein the top surface that extends from a first side of the first housingtowards a second side of the first housing opposite the first side ofthe first housing; and a second housing having a bottom surface, thesecond housing comprising: a computing system having a processor that isconfigured to receive data sensed by the sensor, the processor beingconfigured to detect, from the received data, when the catheter ispartially occluded but not yet fully occluded, the computing systemfurther comprising a communication unit by which the processorwirelessly transmits an output signal to a receipt location when theprocessor detects that the catheter is partially occluded; a secondelectrical contact that connects to the computing system, the secondelectrical contact being embedded in the bottom surface; and aprotrusion that extends downwardly from the bottom surface, theprotrusion extending from a first side of the second housing towards asecond side of the second housing opposite the first side of the secondhousing, the protrusion being configured to slide into the groove in thetop surface of the first housing to thereby secure the first housing tothe second housing, wherein the protrusion and the groove are configuredsuch that, when the protrusion is fully slid into the groove the bottomsurface is secured against and aligned with the top surface and thesecond electrical contact aligns with and contacts the first electricalcontact. wirelessly transmitting an output signal to the receiptlocation, wherein the output signal is based on data sensed by thesensor.
 31. The method of claim 30, further comprising determining apresence of an occlusion within the catheter assembly based on the datasensed by the sensor, wherein the output signal is wirelesslytransmitted to the receipt location in response to determining thepresence of the occlusion within the catheter assembly.
 32. The methodof claim 31, wherein the sensor comprises a pressure sensor, whereindetermining the presence of the occlusion within the catheter assemblybased on the data sensed by the sensor comprises determining theocclusion is partial in response to detecting a mean maximum pressurebetween 14 psi and 42.5 psi, further comprising providing an alert inresponse to determining the occlusion is partial.
 33. The method ofclaim 31, wherein the sensor comprises a pressure sensor, whereindetermining the presence of the occlusion within the catheter assemblybased on the data sensed by the sensor comprises determining theocclusion is full in response to detecting a mean maximum pressure of atleast 42.5 psi, further comprising: providing an alert in response todetermining the occlusion is full.
 34. The method of claim 31, whereindetermining the presence of the occlusion within the catheter assemblybased on the data sensed by the sensor comprises determining based onthe data sensed by the sensor a pressure within the catheter assembly isgreater than a threshold value.
 35. The method of claim 30, furthercomprising another sensor disposed within the fluid pathway.
 36. Themethod of claim 35, wherein the sensor is a pressure sensor, wherein theother sensor is another pressure sensor, further comprising determiningbased on the data sensed by the sensor and the other sensor a fluid flowdirection within the catheter assembly.
 37. A monitoring device tomonitor a status of a catheter, comprising: a housing comprising adistal end, a proximal end, and a fluid pathway extending through theproximal end and the distal end, wherein the distal end comprises aconnector configured to couple to a catheter assembly; a sensor disposedwithin the fluid pathway; and a communication unit configured towirelessly transmit an output signal to a receipt location, wherein theoutput signal is based on data sensed by the sensor.
 38. The monitoringdevice of claim 37, wherein the housing is a first housing, furthercomprising a second housing, wherein the second housing is removablycoupled to the first housing, wherein the second housing comprises aprinted circuit board, a power supply, and an electrical contact,wherein the communication unit is disposed on the printed circuit board,wherein the first housing further comprises a another electrical contactoperably coupled to the electrical contact of the second housing. 39.The monitoring device of claim 37, further comprising a printed circuitboard disposed within the housing, wherein the printed circuit boardcomprises a processor, wherein the processor is configured to determinea presence of an occlusion in the catheter assembly based on the datasensed by the sensor, wherein in response to the processor determiningthe presence of the occlusion based on the data sensed by the sensor,the communication unit transmits the output signal to the receiptlocation.